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India gives emergency use approval to Sputnik V: All you need to know about the third vaccine approved by DCGI

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Sputnik V also requires it to be administered in two shots.

Sputnik V in India: On Monday, India gave emergency use authorisation to Russia’s Sputnik V, making it the third vaccine to be used in India, with the first two being Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. The vaccine had been recommended for emergency use approval by an expert panel, after which drug regulator Drugs Controller General of India gave it the green light.

The vaccine was developed by Moscow-based Gamaleya National Research Institute of Epidemiology and Microbiology. Sputnik V makes use of two different adenoviruses, which cause the common cold among humans. While the adenoviruses are made weaker so that they are unable to replicate in humans, they are also modified in a way that the vaccine would deliver a code that would make the spike protein of the coronavirus. With this, the vaccine tries to ensure that if/when the real virus enters the body of the vaccinated person, an immune response of antibodies is triggered.

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Sputnik V also requires it to be administered in two shots, but it uses different vectors for each shot. According to the Russian Direct Investment Fund (RDIF), this method leads to a longer immunity among the individuals vaccinated with Sputnik V as against those who received dosage of vaccines that used the same delivery mechanism for both the shots. For Sputnik V, the two doses are given at an interval of 21 days.

The vaccine needs to be stored at a temperature of -18 degrees Celsius if it is being stored in its liquor form. On the other hand, if it is being stored in a freeze-dried form, a temperature of 2 degrees Celsius to 8 degrees Celsius is optimal, and this can be done in a conventional refrigerator, eliminating the need to additionally invest in cold-chain storage facilities. More than 55 countries have so far given approval to the Russian vaccine.

In India, Hyderabad-based Dr Reddy’s Laboratories was working on the clinical trials of Sputnik V and had filed for government’s approval. Dr Reddy’s Lab had partnered with the RDIF in September last year. Earlier, the DCGI had sought more details from Dr Reddy’s Lab but on Monday, it finally gave the go ahead.

Apart from Dr Reddy’s Lab, RDIF has collaborated with five other pharma companies in India for the vaccine – Hetero Biopharma, Panacea Biotec, Gland Pharma, Stelis Biopharma and Virchow Biotech. Collectively, it is expected that these partnerships will lead to a manufacturing capacity of 600 million doses a year in India for Sputnik V.

In Russian phase 3 clinical trials, the vaccine had shown an efficacy of 91.6%, and a bridging study was conducted by Dr Reddy’s Lab in India before it applied for emergency use approval. Moreover, no strong allergies were found to be caused by the vaccine.

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